NDC | 50382-051-01, 50382-051-02, 50382-051-03 |
Set ID | 1deec882-5c29-44f8-8a74-4ec5bed2eadc |
Category | HUMAN OTC DRUG LABEL |
Packager | Galentic Pharma (India) Priva Te Limited |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART347 |
- ACTIVE INGREDIENT
- Uses:
- Warnings:
- When using this product:
- Stop use and ask a doctor if:
- Do not use on:
- Keep out of reach of children
-
Directions:
For diaper rash:
- change wet and soiled diapers promptly
- cleanse the diaper area and allow to dry
- apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
For poison ivy, poison oak, poison sumac:
- apply liberally as often as needed
- Inactive Ingredients
- Principal Display
-
INGREDIENTS AND APPEARANCE
ZINC OXIDE
zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50382-051 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 200 mg in 1 g Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETETH-20 (UNII: I835H2IHHX) LIGHT MINERAL OIL (UNII: N6K5787QVP) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50382-051-03 72 in 1 CASE 1 28.34 g in 1 TUBE 2 NDC:50382-051-01 72 in 1 CASE 2 56.68 g in 1 TUBE 3 NDC:50382-051-02 12 in 1 CASE 3 425.1 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 07/19/2013 Labeler - Galentic Pharma (India) Priva Te Limited (918531450) Establishment Name Address ID/FEI Business Operations Galentic Pharma (India) Priva Te Limited 918531450 manufacture(50382-051)